Dinutuximab Side Effects
Medically reviewed by Drugs.com. Last updated on Jul 15, 2024.
Applies to dinutuximab: intravenous solution.
Important warnings
This medicine can cause some serious health issues
Intravenous route (solution)
Serious and possibly life-threatening infusion reactions have been reported in 26% of patients receiving treatment with dinutuximab.
Administer prehydration and premedication prior to each infusion and monitor patients for signs and symptoms of infusion reactions during treatment and for at least 4 hours after the infusion is completed.
If severe infusion reactions occur during treatment, immediately stop the infusion.
Permanently discontinue use if anaphylaxis occurs.
Dinutuximab causes serious neurologic adverse reactions including severe neuropathic pain in most patients, as well as peripheral neuropathy (eg, peripheral sensory neuropathy, severe motor neuropathy).
Not all cases of neuropathy were resolved during clinical trials.
Administer IV opioids prior to, during, and for 2 hours after completion of treatment.
Discontinue use if severe unresponsive pain, severe sensory neuropathy, or moderate to severe peripheral motor neuropathy occur.
Precautions
Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to receive it. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for 2 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine may cause a rare but serious type of an allergic reaction called an infusion reaction. This can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child start to have cough, trouble breathing, hives, itching, or skin rash, lightheadedness, dizziness, or fainting, tightness in the chest, or swelling of the face or lips.
Check with your doctor right away if you or your child are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.
Tell your doctor right away if you or your child have a cloudy urine, change in the amount of urine, fainting or lightheadedness, nausea, stomach pain, or swelling of the hands, ankles, or feet after receiving this medicine. These may be symptoms of a rare but serious condition called capillary leak syndrome.
This medicine could lower your blood pressure too much and cause you to feel dizzy or lightheaded. Stand or sit up slowly if you are dizzy. Low blood pressure is more likely to happen when you begin to use the medicine.
This medicine may cause reversible posterior leukoencephalopathy syndrome (RPLS). Tell your doctor if you have severe headache, changes in vision, fast, pounding, or uneven heartbeat, seizures, unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness.
Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).
Dinutuximab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
- If you can, avoid people with infections. Check with your doctor immediately if you or your child think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
- Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
- Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
- Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
- Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
- Avoid contact sports or other situations where bruising or injury could occur.
Tell your doctor right away if you or your child have black, tarry stools, blood in the urine, fever, increased or decreased urination, pinpoint red spots on the skin, stomach pain, swelling of the face, fingers, feet, or lower legs, unusual bleeding, bruising, or weakness, or yellow eyes or skin after receiving this medicine. These may be symptoms of hemolytic uremic syndrome.
Serious side effects of dinutuximab
Along with its needed effects, dinutuximab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking dinutuximab:
More common side effects
- black, tarry, stools
- bleeding gums
- blood in the urine or stools
- blurred vision
- chills
- cloudy urine
- coma
- confusion
- convulsions
- cough or hoarseness
- decrease or increase in the amount of urine
- difficult or labored breathing
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- fainting or lightheadedness
- fast or irregular heartbeat
- fever
- headache
- hives or welts, itching, or skin rash
- increased thirst
- irregular heartbeat
- loss of appetite
- lower back or side pain
- muscle pain or cramps
- nausea or vomiting
- noisy breathing
- numbness or tingling in the hands, feet, or lips
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- redness of the skin
- sore throat
- stomach pain
- sweating
- swelling of the face, hands, ankles, feet, or lower legs
- tightness in the chest
- troubled breathing with exertion
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
Less common side effects
- back pain
- bigger, dilated, or enlarged pupils (black part of the eye)
- burning, numbness, tingling, or painful sensations
- change in color vision
- change in the ability to see colors, especially blue or yellow
- chest pain
- difficulty seeing at night
- drooping upper eyelids
- increased sensitivity of the eyes to sunlight
- muscle or joint pain
- nerve pain
- pain in the arms or legs
- unsteadiness or awkwardness
- weakness in the arms, hands, legs, or feet
Incidence not known
- yellow eyes or skin
Other side effects of dinutuximab
Some side effects of dinutuximab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common side effects
- diarrhea
For healthcare professionals
Applies to dinutuximab: intravenous solution.
General adverse events
The most common adverse drug reactions (25% or more) are pain, pyrexia, thrombocytopenia, lymphopenia, infusion reactions, hypotension, hyponatremia, increased alanine aminotransferase, anemia, vomiting, diarrhea, hypokalemia, capillary leak syndrome, neutropenia, urticaria, hypoalbuminemia, increased aspartate aminotransferase, and hypocalcemia.
Dermatologic
- Very common (10% or more): Urticaria (37%)[Ref]
Gastrointestinal
- Very common (10% or more): Pain (85%) (e.g., gingival pain, proctalgia, oropharyngeal pain, abdominal pain, abdominal pain upper), vomiting (46%), diarrhea (43%), nausea (10%)[Ref]
Genitourinary
- Very common (10% or more): Pain (85%) (e.g., bladder pain), proteinuria (16%)[Ref]
Hematologic
- Very common (10% or more): Thrombocytopenia (66%), lymphopenia (62%), anemia (51%), neutropenia (39%)[Ref]
Hepatic
- Very common (10% or more): Increased alanine aminotransferase (56%), increased aspartate aminotransferase (28%)[Ref]
Hypersensitivity
- Very common (10% or more): Infusion reactions (66%)[Ref]
Immunologic
- Very common (10% or more): Patients developing anti-drug antibodies to dinutuximab (18%), sepsis (18%), device related infection (16%)[Ref]
Local
- Very common (10% or more): Infusion related pain (85%)[Ref]
Metabolic
- Very common (10% or more): Hyponatremia (58%), hypokalemia (43%), hypoalbuminemia (33%), hypocalcemia (27%), hypophosphatemia (20%), hyperglycemia (16%), hypertriglyceridemia (16%), decreased appetite (up to 15%), hypomagnesemia (12%), increased weight (10%)[Ref]
Musculoskeletal
- Very common (10% or more): Pain (85%) (e.g., arthralgia, back pain, bone pain, chest pain, facial pain, musculoskeletal chest pain, myalgia, nick pain, pain in extremity)[Ref]
Nervous system
- Very common (10% or more): Peripheral neuropathy (13%)[Ref]
Ocular
- Frequency not reported: Blurred vision, photophobia, mydriasis, fixed or unequal pupils, optic nerve disorder, eyelid ptosis, papilledema, loss of vision[Ref]
Other
- Very common (10% or more): Pain (85%) (e.g., abdominal pain, abdominal pain upper, arthralgia, back pain, bladder pain, bone pain, chest pain, facial pain, gingival pain, musculoskeletal chest pain, myalgia, neck pain, neuralgia, oropharyngeal pain, pain in extremity, proctalgia), pyrexia (72%), edema (17%)[Ref]
Renal
- Very common (10% or more): Increased serum creatinine (15%)[Ref]
Respiratory
- Very common (10% or more): Hypoxia (24%)[Ref]
Cardiovascular
- Very common (10% or more): Hypotension (60%), capillary leak syndrome (40%), hemorrhage (17%) (including gastrointestinal hemorrhage, hematochezia, rectal hemorrhage, hematemesis, upper GI hemorrhage, hematuria, hemorrhage urinary tract, renal hemorrhage, epistaxis, respiratory tract hemorrhage, disseminated intravascular coagulation, catheter site hemorrhage, hematoma), hypertension (14%), tachycardia (19%) (e.g., tachycardia, sinus tachycardia)[Ref]
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References
1. (2015) "Product Information. Unituxin (dinutuximab)." United Therapeutics Corporation
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Further information
Dinutuximab side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.